Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 006459
Company: LEDERLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HETRAZAN DIETHYLCARBAMAZINE CITRATE 50MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/13/1950 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/10/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/28/1991 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/07/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/07/1985 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1985 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1985 SUPPL-2 Labeling

Label is not available on this site.

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